Narrow Band Imaging Colon Polyp Study

This study has been completed.
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
Midwest Biomedical Research Foundation
Information provided by:
Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00614770
First received: January 31, 2008
Last updated: June 16, 2010
Last verified: June 2010
  Purpose

In this study the investigators hypothesize that High Definition White Light colonoscopy and narrow band imaging (NBI) will detect a higher number of adenomas compared to standard definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp histology compared to high definition colonoscopy and standard colonoscopy.

Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy, high-definition white light colonoscopy and NBI.

Specific Aim 2 - To compare the number of adenoma detected per subject by standard colonoscopy, high-definition white light colonoscopy and NBI.

Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface mucosal and vascular patterns during the procedure.

Specific Aim 4 - To determine the inter-observer agreement between investigators for the recognition of various polyp patterns


Condition Intervention
Adenomatous Polyp
New Imaging Techniques in Colonoscopy
Procedure: standard of care colonoscopy
Procedure: colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multicenter, Prospective, Randomized Controlled Trial for the Detection of Colon Polyps and Predicting Histology

Resource links provided by NLM:


Further study details as provided by Kansas City Veteran Affairs Medical Center:

Primary Outcome Measures:
  • The prevalence of adenomas in the three arms of the study. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Number of subjects with adenomas in the three arms of the study


Secondary Outcome Measures:
  • Secondary outcome will be number of adenomas detected per subject in the three arms, the sensitivity, specificity, and accuracy of predicting polyp histology real time by the three imaging modalities. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 630
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Standard White Light Colonoscopy
Procedure: standard of care colonoscopy

Standard White Light Colonoscopy

one exam per patient

Experimental: 2
High Definition White Light Colonoscopy
Procedure: standard of care colonoscopy

High Definition White Light Colonoscopy

one exam per patient

Experimental: 3
Narrow Band Imaging Colonoscopy
Procedure: colonoscopy

Narrow Band Imaging Colonoscopy

one exam per patient


Detailed Description:

This study is a multi-center randomized controlled trial that will be conducted at the Kansas City VA Medical Center, Kansas City, MO and The Barnes Jewish Hospital, St Louis, MO. Patients referred for screening and surveillance colonoscopy will be enrolled. They will be randomized to one of the following three groups: standard white light colonoscopy, high-definition white light colonoscopy or NBI.

All colonoscopies will be performed at the Kansas City VA Medical Center and The Barnes Jewish Hospital, St Louis, MO. Moderate sedation will be administered for the procedure with intravenous midazolam, demerol or fentanyl and Propofol. In patients randomized to the NBI arm, the colonoscope will be inserted to the cecum under white light and will switch to NBI mode at the time of withdrawal. After cecal intubation, the colonic mucosa will be carefully visualized during withdrawal of the scope with one of the three imaging modalities to which the patient has been randomized. No effort will be made to look for polyps during the insertion of the colonoscope. All polyps detected will be documented for their size, morphology (Polypoid: sessile, pedunculated or Non polypoid: superficially elevated, completely flat, depressed), and location. The surface of the polyp will be assessed during the procedure and the histology will be predicted real time by evaluating the surface mucosal and vascular patterns. The patterns would be classified into one of the four patterns described in our pilot study (tubular and gyrus patterns will be combined to tubulogyrus pattern). Any other patterns detected would be described and kept in the miscellaneous category. If a pattern is not identified on a polyp with either white light or NBI, it will be recorded as such and no attempts will be made to predict histology. Photo documentation of the surface patterns of the polyps will be performed. Polyps will then be removed either with a biopsy forcep or snare and sent for histopathological evaluation. Each polyp removed will have one or more corresponding picture of its surface patterns and these will be labeled accordingly. The total time spent in inspecting the colonic mucosa (excluding the time spent in removal of polyps or clearing the colon of liquid and solid debris) will be measured with a stop watch. Representative images of the various polyp patterns will be reviewed, discussed and standardized amongst all the investigators at both sites. In addition, images of all the polyp patterns will be printed and posted in the endoscopy suites at both hospitals.

The bowel preparation will be evaluated and graded as follow:

Excellent (score=1) - >90% mucosa seen, mostly liquid colonic contents, minimal suctioning needed for adequate visualization.

Good (score=2) - >90% of mucosa seen, mostly liquid colonic contents, significant suctioning needed for adequate visualization Fair (score=3) - > 90% mucosa seen, mixture of liquid and semisolid colonic contents, could be suctioned and/or washed Inadequate (score=4) - <90% mucosa seen, mixture of semisolid ands solid colonic contents, which could not be suctioned or washed

Patients with "Inadequate" (score = 4) bowel prep will be excluded.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • referral for screening or surveillance colonoscopy
  • the ability to provide informed consent

Exclusion criteria:

  • prior surgical resection of any portion of colon
  • prior history of colon cancer
  • history of inflammatory bowel disease
  • use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
  • poor general condition or any other reason to avoid prolonged procedure time
  • history of polyposis syndrome or HNPCC
  • inability to give informed consent.
  • Inadequate bowel preparation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614770

Locations
United States, Missouri
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Kansas City Veteran Affairs Medical Center
American Society for Gastrointestinal Endoscopy
Midwest Biomedical Research Foundation
Investigators
Principal Investigator: Amit Rastogi, MD Kansas City VA Medical Center
  More Information

No publications provided

Responsible Party: Amit Rastogi, MD, Kansas City VA Medical Center
ClinicalTrials.gov Identifier: NCT00614770     History of Changes
Other Study ID Numbers: AR0003, AR0003
Study First Received: January 31, 2008
Last Updated: June 16, 2010
Health Authority: United States: Federal Government
Human Subjects Committee, Kansas City VA Medical Center, Kansas City, MO, USA:

Keywords provided by Kansas City Veteran Affairs Medical Center:
colonoscopy

Additional relevant MeSH terms:
Polyps
Adenomatous Polyps
Pathological Conditions, Anatomical
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014